Global Companion Diagnostics Market By Product And Service (Kits And Reagents, Software And Services), By Technology (Polymerase Chain Reaction, Next Generation Sequencing), By Indication (Lung Cancer, Breast Cancer, Colorectal Cancer), By End-User (Reference Laboratories , Pharmaceutical And Biopharmaceutical Companies), By Region and Companies - Industry Segment Outlook, Market Assessment, Competition Scenario, Trends and Forecast 2023-2032

Report Overview

Companion Diagnostics Market size is expected to be worth around USD 4,786 Million by 2032 from USD 2,452 Million in 2022, growing at a CAGR of 7.1% during the forecast period from 2022 to 2032.

It is now common to believe that drug outcomes can vary between individuals due to advances in genomics and genetic sequencing. The practice of administering the “right drug at the right time, in the right dosage, to the right person” can be made easier by better understanding the biomarkers and genetic characteristics of individuals.

To provide targeted therapies for the right candidate, pharmaceutical and biopharmaceutical companies continue to work with patient-selection diagnostic tools in the early stages of drug development. This supports the expansion of the companion diagnostics market.

Market Scope

Product and Services  Analysis

Assays, reagents and software are the main products and services of companion diagnosis

Many assays, reagents, and kits are used in research, life science, and environmental labs. Assays are used to analyze a substance in order to determine its quality or composition. A kit is a collection or set of equipment, materials or instructions for a specific purpose.

A reagent is chemical that can be used in laboratory testing to make or measure other compounds. Complementary diagnostics can be performed using next-generation sequencing and immunohistochemistry, as well as polymerase chain reaction and next-generation sequencing.

Companion diagnostics can be used to identify lung, breast, colorectal and melanoma tumors. Companion diagnostics are used by pharmaceutical and biopharmaceutical firms, as well as reference laboratories and contract-research organizations.

By Technology Analysis

The Segment Polymerase Chain Reaction is Dominate by Launch of New Products & Regulatory Approvals

Polymerase chain reaction technology has dominated the market share with the launch of new PCR kits by major players such as QIAGEN. Identifying Patients with Non-Small Cell Lung Cancer (NSCLC) Eligible for Treatment with LUMAKRAS, a New Therapy in Development by Amgen Inc.

In March 2021, Thermo Fisher Scientific Inc. announced the launch of the QuantStudio 5 Dx Real-Time PCR System, offering improved and more accurate results. Obtain results from laboratory procedures to help maintain your molecular diagnostic workflow. New product launches and formal approvals led to this segment dominance in the market.

By Indication Analysis

The Dominance of this Segment was due to an escalating incidence of cancer and the emphasis on key players in innovative technology development

Due to the increasing incidence of cancer, the market share for companion diagnostics in this segment will be dominant. Key players have been focusing on innovation to create advanced tests for cancer drugs and are concentrating on developing innovative technology. The number of biomarker tests for targeted cancer drugs is also increasing.

The World Health Organization (WHO), in February 2022 published statistics showing that approximately 400,000 children are diagnosed with cancer each year. According to statistics from the World Cancer Research Fund International in February 2022, 18,094,716 millions cases of cancer were diagnosed worldwide. F. Hoffmann-La Roche Ltd was approved by the FDA in July 2020 for its VENTANA HER2 dual ISH DNA probe cocktail assay. This assay is a companion diagnostic to Herceptin (trastuzumab), therapy and helps in detecting HER2 biomarkers.

Due to the development of Central Nervous System disease (CNS), such as Schizophrenia and Parkinson’s, the neurology segment will grow at the highest CAGR. This allows for precision medicine and companion diagnostics to provide better diagnostic tools. Fujirebio introduced two new tests in May 2022: Lumipulse G-b-Amyloid 1-42 plasma and Lumipulse G-b-Amyloid1-40 Plasma. These are both assays for LUMIPULSE G. These chemiluminescent enzyme immuneassays (CLEIA assays) can measure the b–amyloid1-42 or b–amyloid1–40 in plasma.

End-User Analysis

Collaborations with Manufacturers Leading to the Significant Share of the Pharmaceutical & Biopharmaceutical Companies Segment.

In 2022, the largest market share was held by pharmaceutical and biopharmaceutical firms. This segment was dominated by collaborations with companion diagnostic companies. In November 2021, Burning Rock Biotech Limited partnered with Merck KGaA in order to create the MET inhibitor tepotinib.

The company’s next-generation sequencing liquid biopsy method, known as the OncoCompass Target Panel, is the basis for this companion diagnostic test. Burning Rock Biotech Limited formed a global strategic partnership with IMPACT Therapeutics in August 2021. This collaboration will develop a companion diagnostic (CDx), test to monitor the progress of drugs in synthetic lethality. Due to technological advances and new product launches, the pharmaceutical & biopharmaceutical company segment will grow at the highest rate during the forecast period.

This segment is involved in the continuous development of companion diagnostics testing for multiple indications. Illumina Inc. and Boehringer Ingelheim teamed up in January 2022 to create new tests for different programs within Boehringer Ingelheim’s oncology pipeline. This collaboration helped accelerate the development of precision medicine for advanced cancer patients.

Key Market Segments

By Product and Service

• S Assays
• Kits and Reagents
• Software and Services

By Technology

• Polymerase Chain Reaction
• Next Generation Sequencing
• In Situ Hybridization
• Immunohistochemistry

By Indication 

• Lung Cancer
• Breast Cancer
• Colorectal Cancer
• Leukemia
• Melanoma

By End-User 

• Pharmaceutical and Biopharmaceutical Companies
• Reference Laboratories
• Contract Research Organizations

Market Dynamics

Drivers

Increasing Prevalence of Cancer to Augment Market Growth

In recent years, the incidence of cancer has increased significantly. The increasing number of cases of cancer has increased the demand for CDx assays that are accurate and reliable. Genomic testing gives doctors precise information about how to treat patients. CDx products are seeing an increase in sales due to the rising incidence of cancer.

Canadian statistics show that 229,200 new cases of cancer were diagnosed in Canada in November 2021. According to the World Health Organization, in 2022 there were 2.26 million new cases of breast cancer, and 2.21 million people with lung cancer. To meet this growing demand, new tests are being developed that can diagnose specific types mutations.

The Guardant360 CDx was approved by the U.S. FDA in August 2020. The first liquid biopsy companion diagnostic uses Next-Generation Sequencing technology (NGS) to identify patients suffering from specific mutations in the Epidermal Growth Factor Receptor gene (EGFR), metastatic non-small cell lung cancer (NSCLC). This has driven the global demand for these tests, and it is also responsible for the market’s continued growth. 

Regulatory Approvals of New Tests for Different Indications to Stimulate Market Growth

The market is growing as more products are approved. This is leading to the adoption of many tests and thereby increasing the market share. Key manufacturers are also focusing on developing new tests to increase the market for companion diagnostics.

This kit evaluates multiple tumor biomarkers in order to determine specific molecular profiles for a patient with cancer. Agilent Technologies Inc. was approved for its PD-L1 IHC22C3 pharmDx. This is a qualitative immunohistochemically test. This test is used to determine if KEYTRUDA (anti PD-1 therapy), may be a suitable treatment option for patients with cervical cancer. These factors will support market growth strongly. 

Growing need for targeted medicines

Global healthcare spending is increasing, which will raise awareness among common people about safety in daily life and hygiene. Hygiene can be used to reduce the chance of getting contaminated or infected by microorganisms.

Due to increased awareness of hygiene, the market for hand sanitizers is expected to grow. Coronavirus was prevalent during a time when both the mortality rate and cost of treatment were high. To prevent the spread of the virus, hand sanitizers and wearing masks are essential.

It can also be used in clinics and laboratories to disinfect equipment and prevent the spread of bacteria. There are many benefits to hand sanitizers, such as the ability to clean surfaces, disinfect keyboards, remove nail polish, and kill bacteria. This will help drive market growth. 

Restraints

Incompetent Reimbursement Scenario and Stringent Regulatory.

Despite growing acceptance, there is no standard method for setting the reimbursement rate for companion diagnostic tests. Each case is different and reimbursement rates are determined individually. According to Taylor Wessing LLP’s article in Germany, reimbursement for outpatients and inpatients is different in June 2022.

Diagnostics are mostly covered by diagnosis-related group for inpatient care. Outpatient care is covered according to the specific list of reimbursable treatments. A standard regulatory framework is not available for companion diagnostics (CDx). The clinical development and regulation companion diagnostics (CDx) is not without its challenges.

This regulatory framework plays an important role in determining sensitivity and specificity, while also making a therapeutic decision. In vitro diagnostic medical device regulation (IVDR) is being implemented by the European Union. The new regulation introduces a broad range of strict requirements regarding scientific validity and clinical performance.

According to a 2021 article in Biomarker Insights, the conformity process for companion diagnostic (CDx), must be conducted by a medical authority and notified entity. This timeframe can be extended to 60 days. The key factor in the adoption of devices is the availability of suitable reimbursement policies and regulations. The lack of reimbursement policies and strict regulations will hinder global adoption and market growth over the forecast period.

Opportunity

A companion diagnostic is an in-vitro medical device that provides essential information for safe and effective use a drug or biological product. This test can help a healthcare professional determine if a therapeutic product is beneficial for patients. It can also outweigh any possible side effects.

Due to a surge in R&D for targeted therapies, increase in demand for personalized medical care with increased awareness in emerging countries, discovery of biomarkers for different conditions and higher unmet cancer treatment needs, the global companion diagnostics industry is set to see significant growth over the forecast period.

Trends

Next-Generation Sequencing is a technique used by clinicians to determine the number of genes that are responsible for the development of cancer. This test is done on a surgically removed tumor. NGS technology is developing and provides high output in a short time.

According to a CDC article, next-generation sequencing has moved from clinical use to research in the last five years. Key players are also introducing new testing solutions to the market. The new market trend in companion diagnostics is the advancement in next-generation sequencing, which can detect genetic abnormalities and help in specific diseases.

Illumina Inc. teamed up with Soma Logic Operating Co. Inc. in January 2022 to introduce Soma Scan, an assay for proteomics, onto Illumina’s high-throughput next-generation sequencing platforms.

COVID-19 Impact Analysis

Decline in the Number of Tests Performed during COVID-19 Owing to Lower Diagnosis of Cancer

The demand for companion diagnostics has been hampered by the emergence COVID-19. Due to a drop in testing volume, major players in the market saw a decline in revenue. The market saw a slower growth rate of 15.1% in 2020, compared with 19.8% in 2019.

Major players saw a substantial decline in their revenue during 2020. Myriad Genetics Inc. saw a 34.5% decline in molecular diagnostics revenues in 2020, compared to 2019. In 2020, Abbott Laboratories also reported a 4.0% decrease in core laboratory diagnostics revenues compared to 2019.

The key factors that contributed to the recovery of testing in 2020 were the lifting of lockdown restrictions, stay at home orders in many countries and the launches of new diagnostics tests as well as reestablishing the supply chain network. The 2021 recovery of testing in cancer diagnostics and new diagnostic tests had a positive impact on the demand.

Regional Analysis

North America region accounted significant share of the global companion dignostics market 

This is due to the higher incidence of cancer and other chronic diseases in the region, as well as increased adoption of advanced CDx tests. According to the National Cancer Institute in the USA, there were 1,806,590 new cases in 2020. Europe, however, is expected to be the second-most lucrative region for revenue growth in 2021.

This region has seen a rise in pharmaceutical companies and companion diagnostic makers. QIAGEN and Denovo Biopharma LLC collaborated in December 2021 to create a blood-based companion diagnostic (CDx), which will identify patients who express Denovo Genomic Marker 1(DGM1) and are likely to respond with Denovo’s investigational drug DV102. This drug is used to treat diffuse large B-cell lymphoma in lymphoid tumors.

Asia Pacific is expected to experience the fastest growth rate during the forecast period. This is due to rising cancer rates, improved healthcare infrastructure and growing numbers of medical device companies that are developing treatment products.

Janssen Asia Pacific estimates that Asia Pacific is home to 50% of all new cases of cancer worldwide each year. By 2030, the number of cancer deaths in Asia will increase by 36.0%. Latin America, the Middle East and Africa are expected to grow slower than Asia Pacific.

The region’s major market driver is likely to be partnerships between hospitals and key players for the expansion of precision-oncology diagnostic labs that provide extensive genetic testing to patients with cancer. Geneseeq, for example, announced in July 2022 that it was partnering with Hospital de Base, Brazil to create an NGS-based precision cancer diagnostic lab. This will provide advanced clinical research and genetic testing for patients suffering from cancer in Brazil.

Key Regions

• North America
  • The US
  • Canada
  • Mexico

• Western Europe
  • Germany
  • France
  • The UK
  • Spain
  • Italy
  • Portugal
  • Ireland
  • Austria
  • Switzerland
  • Benelux
  • Nordic
  • Rest of Western Europe

• Eastern Europe
  • Russia
  • Poland
  • The Czech Republic
  • Greece
  • Rest of Eastern Europe

• APAC
  • China
  • Japan
  • South Korea
  • India
  • Australia & New Zealand
  • Indonesia
  • Malaysia
  • Philippines
  • Singapore
  • Thailand
  • Vietnam
  • Rest of APAC

• Latin America
  • Brazil
  • Colombia
  • Chile
  • Argentina
  • Costa Rica
  • Rest of Latin America

• Middle East & Africa
  • Algeria
  • Egypt
  • Israel
  • Kuwait
  • Nigeria
  • Saudi Arabia
  • South Africa
  • Turkey
  • United Arab Emirates
  • Rest of MEA

Market Share & Key Players Analysis

Hoffmann-La Roche Ltd., Agilent Technology Inc. and Abbott are the leading market players due to the new product launches and acquisitions of other players. 

The company’s strong investment in research to create a superior portfolio of treatment options has helped it to be a leader in the market. Agilent Technologies Inc. aquired Resolution Bioscience Inc. in April 2021, which is a leader in next-generation sequencing-based oncology solutions.

The acquisition increased and expanded the company’s capabilities in NGS-based oncology diagnostics. It also provided innovative technology to meet the rapidly growing personalized medicine market. The market is also characterized by small, emerging manufacturers that focus on creating products at a lower cost.

Illumina Inc. has partnered with top biotechnology companies to create companion diagnostics for best-in-class therapeutics. Illumina, Inc. has partnered with Loxo Oncology to develop next-generation sequencing-based companion diagnostics. BioMerieux also created a program for collaboration with medical device and pharmaceutical companies.

Recent Development

• In October 2022 F. Hoffmann-La Roche Ltd. granted PATHWAY, a companion diagnostic that helps to identify certain patients with HER2 metastatic breast cancer who are approved for ENHERTU (HER2-directed anti-drug conjugate) treatment.
• In October 2022: HMNC Brain Health raised US$ 14.2 million in funding to support precision psychiatry programs. In these programs, pharmaceuticals and companion diagnostics are combined to identify patient groups that will benefit from the treatments.
• In June 2022: OmniSeq Corporation announced the launch of OmniSeq INSTsm. This tissue-based test incorporates next-generation sequencing (NGS). This test will improve precision oncology and patient outcomes.
• In August 2021: QIAGEN N.V. and OncXerna Therapeutics Inc. developed Next-Generation Sequencing, (NGS), which is a companion diagnostic to OncXernas’s product candidate, Navicixizumab, which is a product candidate for treating patients with ovarian carcinoma.
• In January 2021 a OmniSeq Corporation announced the launch of OmniSeq INsightsm, a tissue-based test that incorporates next-generation sequencing (NGS). This test will improve precision oncology and patient outcomes.
• In July 2020: OmniSeq Corporation announced the launch of OmniSeq INsightsm. This tissue-based test incorporated NGS technology and was developed by Laboratory Corporation of America Holdings. This test will improve patient outcomes and precision oncology.

Market Key Players

With the presence of many local and regional players, the market for companion diagnostics is fragmented. Market players are subject to intense competition from top market players, particularly those with strong brand recognition and high distribution networks. To stay on top of the market, companies have gained various expansion strategies such as partnerships and product launches.

The following are some of the major players in the global companion diagnostics industry

• Abbott (U.S.)
• Agilent Technologies, Inc. (U.S.)
• F. Hoffmann-La Roche Ltd. (Switzerland)
• Guardant Health (U.S.)
• QIAGEN (Germany)
• Myriad Genetics, Inc. (U.S.)
• Illumina, Inc. (U.S.)
• Thermo Fisher Scientific Inc. (U.S.)
• BIOMERIEUX (France)
• Myriad Genetics, Inc. (U.S.)
• Other Key Players.

Report Scope